DESTINY-Breast03 Phase 3 Study Results
Treatment-Related TEAEs (Grade ≥3)
1.6 mg/kg 3.2 mg/kg 4.8 mg/kg 6.4 mg/kg 8.0 mg/kg 9.6 mg/kg
(n=1)
(n=6)
(n=6)
(n=8)
(n=6)
Any grade ≥3 treatment-related
TEAE, n (%)
0
0
0
2 (25.0)
2 (33.3)
(n=3)
3 (100)
Total
(N=30)
7 (23.3)
Neutrophil count decreased
Anemia
0
0
0
0
2 (33.3)
3 (100)
5 (16.7)
0
0
0
1 (12.5)
0
1 (33.3)
2 (6.7)
Febrile neutropenia
0
0
0
1 (12.5)
0
1 (33.3)
2 (6.7)
Decreased appetite
0
0
0
0
1 (16.7)
0
1 (3.3)
Platelet count decreased
0
0
0
0
0
1 (33.3)
1 (3.3)
Grade ≥3 treatment-related TEAEs occurred in 7 patients (23.3%)
The most common treatment-related TEAEs (nausea, fatigue, and vomiting) had no grade ≥3 events
Two patients experienced DLTs in the 9.6-mg/kg arm (grade 3 febrile neutropenia and grade 4 platelet
count decreased)
Two patients experienced grade 3 treatment-related SAES (anemia and febrile neutropenia)
Data cutoff: February 25, 2022.
DLT, dose-limiting toxicity; SAE, serious adverse event; TEAE, treatment-emergent adverse event.
ASCO 2022 #3002 Oral
Daiichi-Sankyo
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